BFS Mechanic

AVEVA DRUG DELIVERY SYSTEMS INC•Tamarac, FL

1d•$25 - $37•Onsite

About The Position

As the subject matter expert for the operation of Blow-Fill-Seal (BFS) equipment, the BFS Technician plays a pivotal role in ensuring the seamless and efficient production of high-quality pharmaceutical products. The BFS Technician will be responsible for equipment changeovers, startup, troubleshooting, and major adjustments during ongoing production. Additionally, the role involves supporting maintenance activities, process optimization, and training operators on standard operating procedures (SOPs) as well as on the job training (OJT). The ideal candidate should possess technical expertise in BFS technology and demonstrate the ability to work effectively in a fast-paced manufacturing environment.

Requirements

High school diploma or equivalent with technical certifications or relevant vocational training.
Minimum 3 years working as a Blow-Fill-Seal (BFS) Mechanic and/or understanding of BFS technology.
Minimum 5 years of working in regulated Food / OTC Pharmaceuticals manufacturing environment.
Excellent writing, communication, and interpersonal skills.
Strong problem-solving skills and the ability to troubleshoot technical issues effectively.
Familiarity with preventive maintenance procedures and routine equipment inspections.
Detail-oriented with a commitment to ensuring quality and adherence to procedures.
Capacity to adapt to changing priorities and work under pressure in a fast-paced production setting.
Willingness to participate in occasional off-shift or on-call duties when required.
Knowledge of regulatory guidelines and cGMP (Current Good Manufacturing Practices).

Nice To Haves

Aseptic filling environment preferred.

Responsibilities

Perform efficient and accurate equipment changeovers to facilitate smooth transitions between different BFS products and configurations.
Ensure proper setup of the BFS parison, mould, and punch during BFS startup and make necessary major adjustments to maintain product quality and production efficiency.
Conduct fill result assessments and vacuum leak tests, ensuring the fill result meets pre-determined acceptance criteria before releasing the BFS line for production.
Respond promptly to any issues that arise during BFS production, troubleshoot equipment malfunctions, and implement corrective measures to minimize manufacturing downtime.
Assist in troubleshooting and making major adjustments to printers and labelers if operators are unable to resolve issues at the printing/labelling line.
Collaborate with factory maintenance Mechanics during major preventive maintenance and repairs, providing technical expertise and support.
Continuously monitor BFS production processes and identify opportunities for improvement, implementing optimization measures to enhance efficiency and product quality.
Revise existing SOPs and develop new ones as needed. Train operators and other team members on proper procedures to ensure adherence to best practices.
Contribute to and conduct training sessions for BFS operators, equipping them with the necessary knowledge and skills to excel in their roles.
Assist in investigations of deviations, incidents, non-conformances, and safety issues, contributing technical expertise and data analysis.
Actively engage and drive the comprehensive training program for BFS processes. This encompasses targeted training initiatives, such as participating in best practices exchanges, industry seminars, and workgroup activities, followed by sharing the acquired knowledge through presentations, with the aim of enhancing the organization's overall understanding and proficiency in BFS technology.
Understand and comply with SOPs, Environmental, Health, Safety, Regulatory and Quality requirements.
Serve as a team member for problem-solving to resolve production and quality issues.
Participate in internal, regulatory and third-party audits.
Participate in department training as a trainer and as a trainee.
Keep effective working relationships with the staff and personnel contacted in the course of duties.
Provide support for process improvement teams.
Support the execution of scheduled routine preventive maintenance tasks on BFS equipment to ensure consistent and reliable operation.
Support routine operation tasks, such as monitoring the BFS equipment during the run, routine adjustments, weight checks and documentation of such activities in the batch record during peak workloads and as a backup while BFS operators are absent during paid time off or sickness.
May be assigned other duties as needed or directed by management to support the efficient functioning of the production process and overall organizational objectives.